MASTERFLOX 40 mg/ml solution for injection for pigs

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Marbofloxacin

Dostopno od:

FATRO S.p.A.

Koda artikla:

QJ01MA93

INN (mednarodno ime):

Marbofloxacin

Odmerek:

40 milligram(s)/millilitre

Farmacevtska oblika:

Solution for injection

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtska skupina:

Pigs

Terapevtsko območje:

marbofloxacin

Terapevtske indikacije:

Antibacterial

Status dovoljenje:

Authorised

Datum dovoljenje:

2015-07-24

Lastnosti izdelka

Health Products Regulatory Authority
18 April 2019
CRN008MX9
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
MASTERFLOX 40 mg/ml solution for injection for pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Marbofloxacin
40 mg
EXCIPIENTS:
Disodium edetate
0.1 mg
For a full list of the excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear yellow solution, with no visible particles.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (pigs for fattening).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of respiratory infections caused by strains of
_Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma _
_hyopneumoniae _susceptible to marbofloxacin_._
4.3 CONTRAINDICATIONS
Do not use in cases where the pathogen involved is resistant to
marbofloxacin and other (fluoro)quinolones (cross-resistance).
Do not use in cases of hypersensivity to the active substance, to any
other quinolone or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
This product does not contain an antimicrobial preservative.
Special precautions for use in animals
Official and local antimicrobial policies should be taken into account
when the product is used. Fluoroquinolones should be
reserved for the treatment of clinical conditions which have responded
poorly, or are expected to respond poorly, to other
classes of antimicrobials.
Whenever possible, fluoroquinolones should only be used based on
susceptibility testing.
Use of the product deviating from the instructions given in the SPC
may increase the prevalence of bacteria resistant to the
fluoroquinolones and may decrease the effectiveness of treatment with
other quinolones due to the potential for cross
resistance.
Health Products Regulatory Authority
18 April 2019
CRN008MX9
Page 2 of 4
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
(Fluoro)quinolones may ca